Acute Upper Extremity TraumaASSISTNCT03943134

Registry of Avive® Soft Tissue Membrane Utilization in Selected Applications of Acute Trauma of the Upper Extremity

An observational study of Acute Upper Extremity Trauma, run by Axogen Corporation at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

A registry study to evaluate the role of Avive® Soft Tissue Membrane in the management of nerve injury associated with acute trauma in the upper extremity. Read more about this study

Who is it for?: Ages 5 to 70 years
Conditions the study is for: Acute Upper Extremity Trauma
What is being tested?: Minimally Processed Human Umbilical Cord Membrane and Standard Surgical Procedures
How many people: 7 participants
Where: 3 sitesUnited States
Study dates: 1 Dec 2018to 17 Dec 2020
How long will I take part?: 12 Months
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 5 to 70 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Subjects who have had surgical intervention for one or more of the targeted acute upper extremity traumas

Who may be able to join

Subjects 5 to 70 years of age, inclusive;
Sign and date an IRB/IEC -approved written informed consent form (ICF) prior to initiation of any study activities;
Group One only: Subject enrollment (ICF completion) must be completed within 2 weeks (7-14 days) post-operatively of the targeted surgical procedure;
Group Two Retrospective subjects only: Sign and date an IRB/IEC - approved written informed consent form (ICF) prior to initiation of any study activities if required per the governing IRB;
Group One only: Subjects who have undergone placement of Avive® Soft Tissue Membrane over at least one exposed nerve, circumferentially, or as an overlay between the exposed nerve(s) and the surrounding wound bed during surgical intervention following one or more of the following targeted acute upper extremity traumas (selected injuries): Spaghetti Wrist, Distal Radius Fractures, Medial Epicondyle Fractures, Flexor Tenolysis at Wrist, and/or Ballistic Injuries in the Forearm and/or Hand. This surgical intervention must have been completed within 60 days from the date of injury;
Group Two only: Subjects who have undergone surgical intervention for one or more of the following targeted acute upper extremity traumas (selected injuries): Spaghetti Wrist, Distal Radius Fractures, Medial Epicondyle Fractures, Flexor Tenolysis at Wrist, and Ballistic Injuries in the Forearm and/or Hand in the past 5 years without placement of a surgical implant over the exposed nerve, circumferentially, or as an overlay between the exposed nerve(s) and the surrounding wound bed during surgical intervention. This surgical intervention must have been completed within 60 days from the date of injury;
Group Two only: Subjects must have at least 1 qualifying post-operative injury assessment;
Subject is willing and able to comply with all aspects of the treatment and evaluation schedule.

Who cannot join

Subjects with complete transection of all nerves affected by one or more of the following selected injuries: Spaghetti Wrist, Distal Radius Fractures, Medial Epicondyle Fractures, Flexor Tenolysis at Wrist, and Ballistic Injuries in the Forearm and/or Hand. Subjects with nerve transection(s) must also have ≥1 affected nerve intact (non-transected) for treatment with Avive® Soft Tissue Membrane (Group One) or without treatment with a surgical implant (Group Two);
Subjects with Type 1 Diabetes Mellitus or Type 2 Diabetes Mellitus requiring regular insulin therapy;
Subjects who are currently receiving, or have previously received, treatment with chemotherapy, radiation therapy, or other known treatment which affects the growth of the neural and/or vascular system;
Subjects that are currently taking, or have previously used, a medication that is known to cause peripheral neuropathy;
Subjects with a history of chronic ischemic condition of the upper extremity; and
Any subject who, at the discretion of the Investigator, is not suitable for inclusion in the study.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Indiana Hand to Shoulder Center
Indianapolis, Indiana, 46260
Upstate Hand Center
Spartanburg, South Carolina, 29307
Florida Orthopaedic Institute
Tampa, Florida, 33609

Other trials in United States

About this study

Official title: A Multicenter, Ambispective, Clinical Outcomes Registry Study of Avive® Soft Tissue Membrane Utilization in Selected Applications of Acute Trauma of the Upper Extremity

A registry study to evaluate the role of Avive® Soft Tissue Membrane in the management of nerve injury associated with acute trauma in the upper extremity.

Read the detailed description

This is a multicenter outcomes registry study of Avive® Soft Tissue Membrane in the management of nerve injuries associated with selected upper extremity acute trauma. The study will evaluate clinical condition, economic impact, and functional outcomes.

Conditions: Acute Upper Extremity Trauma
Being tested: Minimally Processed Human Umbilical Cord Membrane, Standard Surgical Procedures
Keywords: Acute Trauma, Upper Extremity Trauma, Acute Upper Extremity Trauma, Avive, Peripheral Nerve Injury, Nerve Repair
Medical subject headings: Peripheral Nerve Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Minimally Processed Human Umbilical Cord MembraneOther
Implantation of minimally processed human umbilical cord membrane at the time of surgery
Standard Surgical ProceduresOther
Standard surgical intervention for at least one targeted acute upper extremity trauma

Study groups in NCT03943134
Study group	Role	What they receive
Avive® Soft Tissue Membrane		Subjects with utilization of Avive® Soft Tissue Membrane on an impacted but intact nerve during a surgical procedure for one of the following targeted acute upper extremity traumas (selected injuries): Spaghetti Wrist, Distal Radius Fracture, Medial Epicondyle Fracture, Flexor Tenolysis at Wrist, and Ballistic Injuries in the Forearm and/or Hand. Receives: Other: Minimally Processed Human Umbilical Cord Membrane
Standard Surgical Procedures - Control Arm		Subjects who have undergone surgical procedures for the same selected injuries, but without placement of a surgical implant on an impacted but intact nerve. Receives: Other: Standard Surgical Procedures

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in QuickDASH (Disabilities of Arm, Shoulder, Hand) score at 2,4,8,12,16,24, and 52 post-operative weeks (Adult subjects only).
Adult patients will be assessed for changes in functional status using the QuickDASH outcomes assessment. The quickDASH is an abbreviated version of the original DASH outcomes measures and is comprised of an 11-item patient reported questionnaire used to assess physical function and severity of symptoms in patients with musculoskeletal disorders of the upper limb. Each of the items in the quickDASH use a 5-point Likert scale to assess the corresponding severity or functional parameter. The outcome measure is scored based on the formula ([sum of n responses)/n]-1)(25), where n represents the number of completed items. Computed scores range from 0 (no disability) to 100 (most severe disability).
Measured: 2, 4, 8, 12, 16, 24, and 52 weeks
Changes in PROMIS Pediatric Upper Extremity/Parent Proxy Upper Extremity (PUE/PPUE) outcomes assessment at 2,4,8,12,16, 24, and 52 post-operative weeks (Pediatric subjects only)
The Patient Reported Outcome Measurement Information System (PROMIS®) - pediatric Related Measures is a set of person-centered measures that evaluates and monitors a patient's physical health and pain (pediatric patients). Short forms containing fixed sets of 4-10 items or questions are included for each domain. All PROMIS scores are presented as T-scores where the T-score is the standardized score with a mean of 50 (range 20-80) and a standard deviation of 10. Higher scores indicate more of the concept being measures where sometimes the concept is desirable (e.g., physical function) and sometimes this it is undesirable (e.g., fatigue). PROMIS instruments are scored using item-level calibrations based on response patterns by HealthMeasures Scoring Service (https://www.assessmentcenter.net/ac_scoringservice).
Measured: 2, 4, 8, 12, 16, 24, and 52 weeks
Change in Visual Analogue Scale (VAS) For Pain Score at 2, 4, 8, 12, 16, 24, and 52 post-operative weeks
The Visual Analog Scale (VAS) For Pain is a patient reported outcomes scale whereby the patient indicates his/her current pain level by making a mark on a continuous horizontal 10 centimeter (100 millimeter) line. The distance from the 0 millimeter to the patient's mark corresponds to the amount of pain the subject is currently experiencing. VAS for Pain data are recorded as the number of millimeters from the left of the line to the patients mark across the range of 0-100 millimeters, with 0 millimeter representing no pain and 100 millimeters representing "the worst pain imaginable".
Measured: 2, 4, 8, 12, 16, 24, and 52 weeks
Changes in Reported Pain Using the Faces Pain Scale-Revised Scale (FPS-R) assessment at 2, 4, 8, 12, 16, 24, and 52 post-operative weeks
Pediatric patients will be assessed for changes in patient reported outcomes using the FPS-R. The Faces Pain Scale - Revised (FPS-R) is a self-report measure of pain intensity developed for children. It was adapted from the Faces Pain Scale to make it possible to score the sensation of pain on the widelya accepted calculated 0-to-10 metric. The scale shows a close linear relationship with visual analog pain scales across the age range of 4-16 years. The calculated score ranges from 0 ("no pain") to 10 ("very much pain").
Measured: 2, 4, 8, 12, 16, 24, and 52 weeks
Changes in patient reported health status Using SF-36 patient reported health survey at 2, 4, 8, 12, 16, 24, and 52 post-operative weeks
Adult patients will be assessed for changes in patient reported health status using the SF-36 patient reported health survey. The SF-36 measures overall health status and consists of eight scaled scores which are the weighted sums of the questions in their section. Each scale is directly translated into a 0-100 metric scale. Scoring ranges from 0 (maximum disability to 100 (no disability).
Measured: 2, 4, 8, 12, 16, 24, and 52 weeks
Changes in KINDL Health-Related Quality of Life questionnaire for children at 2, 4, 8, 12, 16, 24, and 52 post-operative weeks
The KINDL is a generic quality of life instrument used to assess Health-Related Quality of Life in children and adolescents aged 3 years and older. The questionnaire is comprised of 24 items which assess various quality of life domains using 5-point Likert scales. Calculated scores range from 0 (lower quality of life) to 100 (higher quality of life).
Measured: 2, 4, 8, 12, 16, 24, and 52 weeks
Change in Patient Rated Wrist Evaluation
Patients will be assessed for changes in patient reported outcomes using the Patient Rated Wrist Evaluation (PRWE)(Applicable to Injuries Affecting the Wrist)
Measured: 2, 4, 8, 12, 16, 24, and 52 weeks
Change in Sensory Function as measured by Medical Research Council Classification (MRCC) for Sensory Recovery
Patients will be assessed for changes in 2-Point Discrimination on a scale from 0 to 4 with 0 representing no sensation and 4 representing a 2-point discrimination measure between 2-6 representing normal sensation.
Measured: 2, 4, 8, 12, 16, 24, and 52 weeks
Change in Motor Function as measured by Medical Research Council Classification (MRCC) for Motor Recovery
Patients will be assessed for changes in muscle strength measured on a scale from 0 to 5, with 0 equal to no movement and 5 equal to normal muscle contraction against resistance.
Measured: 2, 4, 8, 12, 16, 24, and 52 weeks
Change in Motor Function as measured by Grip and Pinch Strength
Patients will be assessed for changes in grip and pinch strength measured in kg force
Measured: 2, 4, 8, 12, 16, 24, and 52 weeks
Change in Motor Function as measured by Range of Motion
Patients will be assessed for changes in range of motion measured in degrees
Measured: 2, 4, 8, 12, 16, 24, and 52 weeks
Change in Tinel's Sign
Patients will be assessed for presence of Tinel's Sign
Measured: 2, 4, 8, 12, 16, 24, and 52 weeks
Incidence of Adverse Events Associated with the Placement of Avive Soft Tissue Membrane
Adverse events are defined as any untoward event experienced by a patient that is related to the nerve repair (whether or not considered product related by the Principal Investigator or Sponsor) or any even that has changed adversely in nature, severity or frequency.
Measured: 2, 4, 8, 12, 16, 24, and 52 weeks
Health Care Economic Impact based on Resource Utilization and Associated Costs
Patients will be assessed for cost of procedures, post-procedure medications, rehabilitation, re-hospitalization
Measured: 2, 4, 8, 12, 16, 24, and 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 201817 Dec 2020

First posted9 May 2019
Study start1 Dec 2018
Primary completion17 Dec 2020
Study completion17 Dec 2020

Why it stopped: Axogen suspended market availability of the Avive® Soft Tissue Membrane effective June 1, 2021. This decision was not related to any safety concerns or product quality issues.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Acute Upper Extremity TraumaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Other
Enrolment: 7 participants (actual)
Target duration: 12 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT03943134
Sponsor's protocol ID: ASM-CP-001
Acronym: ASSIST
Status last verified: Aug 2025
First submitted: 6 May 2019
Last updated: 20 Aug 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acute Upper Extremity Trauma trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Ambispective, Clinical Outcomes Registry Study of Avive® Soft Tissue Membrane Utilization in Selected Applications of Acute Trauma of the Upper Extremity
ClinicalTrials.gov ID: NCT03943134
Acronym / sponsor ID: ASSIST / ASM-CP-001
Conditions: Acute Upper Extremity Trauma
Keywords: Acute Trauma, Upper Extremity Trauma, Acute Upper Extremity Trauma, Avive, Peripheral Nerve Injury, Nerve Repair
Study type: Observational
Recruitment status: TerminatedReason stopped: Axogen suspended market availability of the Avive® Soft Tissue Membrane effective June 1, 2021. This decision was not related to any safety concerns or product quality issues.
Enrolment: 7 participants (actual)
Lead sponsor: Axogen CorporationIndustry (pharma, biotech, devices)
Study start: 1 Dec 2018 (actual)
Primary completion: 17 Dec 2020 (actual)
Study completion: 17 Dec 2020 (actual)
First posted: 9 May 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A registry study to evaluate the role of Avive® Soft Tissue Membrane in the management of nerve injury associated with acute trauma in the upper extremity.

Detailed description

Study design

Observational model: Cohort
Time perspective: Other
Target follow-up: 12 Months
Number of arms: 2

Arm	Type	Receives
Avive® Soft Tissue Membrane	–	Other: Minimally Processed Human Umbilical Cord MembraneSubjects with utilization of Avive® Soft Tissue Membrane on an impacted but intact nerve during a surgical procedure for one of the following targeted acute upper extremity traumas (selected injuries): Spaghetti Wrist, Distal Radius Fracture, Medial Epicondyle Fracture, Flexor Tenolysis at Wrist, and Ballistic Injuries in the Forearm and/or Hand.
Standard Surgical Procedures - Control Arm	–	Other: Standard Surgical ProceduresSubjects who have undergone surgical procedures for the same selected injuries, but without placement of a surgical implant on an impacted but intact nerve.

Who may qualify

Ages: 5 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Subjects who have had surgical intervention for one or more of the targeted acute upper extremity traumas

Key inclusion criteria (8 listed)

Subjects 5 to 70 years of age, inclusive;
Sign and date an IRB/IEC -approved written informed consent form (ICF) prior to initiation of any study activities;
Group One only: Subjects who have undergone placement of Avive® Soft Tissue Membrane over at least one exposed nerve, circumferentially, or as an overlay between the exposed nerve(s) and the surrounding wound bed during surgical intervention following one or more of the following targeted acute upper extremity traumas (selected injuries): Spaghetti Wrist, Distal Radius Fractures, Medial Epicondyle Fractures, Flexor Tenolysis at Wrist, and/or Ballistic Injuries in the Forearm and/or Hand. This surgical intervention must have been completed within 60 days from the date of injury;
Group Two only: Subjects who have undergone surgical intervention for one or more of the following targeted acute upper extremity traumas (selected injuries): Spaghetti Wrist, Distal Radius Fractures, Medial Epicondyle Fractures, Flexor Tenolysis at Wrist, and Ballistic Injuries in the Forearm and/or Hand in the past 5 years without placement of a surgical implant over the exposed nerve, circumferentially, or as an overlay between the exposed nerve(s) and the surrounding wound bed during surgical intervention. This surgical intervention must have been completed within 60 days from the date of injury;
Group Two only: Subjects must have at least 1 qualifying post-operative injury assessment;

Key exclusion criteria (6 listed)

Subjects with complete transection of all nerves affected by one or more of the following selected injuries: Spaghetti Wrist, Distal Radius Fractures, Medial Epicondyle Fractures, Flexor Tenolysis at Wrist, and Ballistic Injuries in the Forearm and/or Hand. Subjects with nerve transection(s) must also have ≥1 affected nerve intact (non-transected) for treatment with Avive® Soft Tissue Membrane (Group One) or without treatment with a surgical implant (Group Two);
Subjects with Type 1 Diabetes Mellitus or Type 2 Diabetes Mellitus requiring regular insulin therapy;
Subjects who are currently receiving, or have previously received, treatment with chemotherapy, radiation therapy, or other known treatment which affects the growth of the neural and/or vascular system;
Subjects that are currently taking, or have previously used, a medication that is known to cause peripheral neuropathy;
Subjects with a history of chronic ischemic condition of the upper extremity; and

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Minimally Processed Human Umbilical Cord MembraneImplantation of minimally processed human umbilical cord membrane at the time of surgery	Other	Avive® Soft Tissue Membrane
Standard Surgical ProceduresStandard surgical intervention for at least one targeted acute upper extremity trauma	Other	Standard Surgical Procedures - Control Arm

Primary outcome

Changes in QuickDASH (Disabilities of Arm, Shoulder, Hand) score at 2,4,8,12,16,24, and 52 post-operative weeks (Adult subjects only).
Time frame: 2, 4, 8, 12, 16, 24, and 52 weeks
Adult patients will be assessed for changes in functional status using the QuickDASH outcomes assessment. The quickDASH is an abbreviated version of the original DASH outcomes measures and is comprised of an 11-item patient reported questionnaire used to assess physical function and severity of symptoms in patients with musculoskeletal disorders of the upper limb. Each of the items in the quickDASH use a 5-point Likert scale to assess the corresponding severity or functional parameter. The outcome measure is scored based on the formula ([sum of n responses)/n]-1)(25), where n represents the number of completed items. Computed scores range from 0 (no disability) to 100 (most severe disability).
Changes in PROMIS Pediatric Upper Extremity/Parent Proxy Upper Extremity (PUE/PPUE) outcomes assessment at 2,4,8,12,16, 24, and 52 post-operative weeks (Pediatric subjects only)
Time frame: 2, 4, 8, 12, 16, 24, and 52 weeks
The Patient Reported Outcome Measurement Information System (PROMIS®) - pediatric Related Measures is a set of person-centered measures that evaluates and monitors a patient's physical health and pain (pediatric patients). Short forms containing fixed sets of 4-10 items or questions are included for each domain. All PROMIS scores are presented as T-scores where the T-score is the standardized score with a mean of 50 (range 20-80) and a standard deviation of 10. Higher scores indicate more of the concept being measures where sometimes the concept is desirable (e.g., physical function) and sometimes this it is undesirable (e.g., fatigue). PROMIS instruments are scored using item-level calibrations based on response patterns by HealthMeasures Scoring Service (https://www.assessmentcenter.net/ac_scoringservice).
Change in Visual Analogue Scale (VAS) For Pain Score at 2, 4, 8, 12, 16, 24, and 52 post-operative weeks
Time frame: 2, 4, 8, 12, 16, 24, and 52 weeks
The Visual Analog Scale (VAS) For Pain is a patient reported outcomes scale whereby the patient indicates his/her current pain level by making a mark on a continuous horizontal 10 centimeter (100 millimeter) line. The distance from the 0 millimeter to the patient's mark corresponds to the amount of pain the subject is currently experiencing. VAS for Pain data are recorded as the number of millimeters from the left of the line to the patients mark across the range of 0-100 millimeters, with 0 millimeter representing no pain and 100 millimeters representing "the worst pain imaginable".
Changes in Reported Pain Using the Faces Pain Scale-Revised Scale (FPS-R) assessment at 2, 4, 8, 12, 16, 24, and 52 post-operative weeks
Time frame: 2, 4, 8, 12, 16, 24, and 52 weeks
Pediatric patients will be assessed for changes in patient reported outcomes using the FPS-R. The Faces Pain Scale - Revised (FPS-R) is a self-report measure of pain intensity developed for children. It was adapted from the Faces Pain Scale to make it possible to score the sensation of pain on the widelya accepted calculated 0-to-10 metric. The scale shows a close linear relationship with visual analog pain scales across the age range of 4-16 years. The calculated score ranges from 0 ("no pain") to 10 ("very much pain").
Changes in patient reported health status Using SF-36 patient reported health survey at 2, 4, 8, 12, 16, 24, and 52 post-operative weeks
Time frame: 2, 4, 8, 12, 16, 24, and 52 weeks
Adult patients will be assessed for changes in patient reported health status using the SF-36 patient reported health survey. The SF-36 measures overall health status and consists of eight scaled scores which are the weighted sums of the questions in their section. Each scale is directly translated into a 0-100 metric scale. Scoring ranges from 0 (maximum disability to 100 (no disability).
Changes in KINDL Health-Related Quality of Life questionnaire for children at 2, 4, 8, 12, 16, 24, and 52 post-operative weeks
Time frame: 2, 4, 8, 12, 16, 24, and 52 weeks
The KINDL is a generic quality of life instrument used to assess Health-Related Quality of Life in children and adolescents aged 3 years and older. The questionnaire is comprised of 24 items which assess various quality of life domains using 5-point Likert scales. Calculated scores range from 0 (lower quality of life) to 100 (higher quality of life).
Change in Patient Rated Wrist Evaluation
Time frame: 2, 4, 8, 12, 16, 24, and 52 weeks
Patients will be assessed for changes in patient reported outcomes using the Patient Rated Wrist Evaluation (PRWE)(Applicable to Injuries Affecting the Wrist)
Change in Sensory Function as measured by Medical Research Council Classification (MRCC) for Sensory Recovery
Time frame: 2, 4, 8, 12, 16, 24, and 52 weeks
Patients will be assessed for changes in 2-Point Discrimination on a scale from 0 to 4 with 0 representing no sensation and 4 representing a 2-point discrimination measure between 2-6 representing normal sensation.
Change in Motor Function as measured by Medical Research Council Classification (MRCC) for Motor Recovery
Time frame: 2, 4, 8, 12, 16, 24, and 52 weeks
Patients will be assessed for changes in muscle strength measured on a scale from 0 to 5, with 0 equal to no movement and 5 equal to normal muscle contraction against resistance.
Change in Motor Function as measured by Grip and Pinch Strength
Time frame: 2, 4, 8, 12, 16, 24, and 52 weeks
Patients will be assessed for changes in grip and pinch strength measured in kg force
Change in Motor Function as measured by Range of Motion
Time frame: 2, 4, 8, 12, 16, 24, and 52 weeks
Patients will be assessed for changes in range of motion measured in degrees
Change in Tinel's Sign
Time frame: 2, 4, 8, 12, 16, 24, and 52 weeks
Patients will be assessed for presence of Tinel's Sign
Incidence of Adverse Events Associated with the Placement of Avive Soft Tissue Membrane
Time frame: 2, 4, 8, 12, 16, 24, and 52 weeks
Adverse events are defined as any untoward event experienced by a patient that is related to the nerve repair (whether or not considered product related by the Principal Investigator or Sponsor) or any even that has changed adversely in nature, severity or frequency.
Health Care Economic Impact based on Resource Utilization and Associated Costs
Time frame: 2, 4, 8, 12, 16, 24, and 52 weeks
Patients will be assessed for cost of procedures, post-procedure medications, rehabilitation, re-hospitalization

Results and safety

The study was stopped early (reason given: Axogen suspended market availability of the Avive® Soft Tissue Membrane effective June 1, 2021. This decision was not related to any safety concerns or product quality issues.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Upper Extremity Trauma, run by Axogen Corporation at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in QuickDASH (Disabilities of Arm, Shoulder, Hand) score at 2,4,8,12,16,24, and 52 post-operative weeks (Adult subjects only). (time frame: 2, 4, 8, 12, 16, 24, and 52 weeks). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03943134.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.